REACT-AF: Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

Status: Recruiting
Location: See all (84) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 85
Healthy Volunteers: f
View:

• 22-85 years of age.

• English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.

• History of non-permanent atrial fibrillation.

• CHA2DS2-VASC score of 1-4 for men and 2-4 for women without prior stroke or Transient Ischemic Attack (TIA), The CHA2DS2-VASc score is a point-based system used to stratify the risk of stroke in Atrial Fibrillation (AF) patients. The acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female). Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and/or ejection fraction \< 40%.

• The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study.

• Willing and able to comply with the protocol, including:

‣ Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan

⁃ Be willing to wear the smart watch for the suggested minimum of 14 hours a day

⁃ Expected to be within cellular service range at least 80% of the time

• Willing and able to discontinue DOAC

• The participant is willing and able to provide informed consent.

Locations
United States
Arizona
Banner University
RECRUITING
Phoenix
California
University of California Los Angeles (UCLA Health)
RECRUITING
Los Angeles
University of Southern California - Keck School of Medicine
RECRUITING
Los Angeles
UC Davis Health
RECRUITING
Sacramento
Scripps Health
RECRUITING
San Diego
Stanford University
RECRUITING
Stanford
Colorado
University of Colorado
RECRUITING
Aurora
South Denver Cardiology Associates, P.C.
RECRUITING
Littleton
Washington, D.c.
Medical Faculty Associates George Washington University
RECRUITING
Washington D.c.
St. Elizabeth's Medical Center
RECRUITING
Washington D.c.
Florida
BayCare Health Systems
RECRUITING
Clearwater
University of Florida
RECRUITING
Gainesville
Mayo Clinic
RECRUITING
Jacksonville
University of Miami - Leonard S. Miller SOM
RECRUITING
Miami
Sarasota Memorial Health Care System
RECRUITING
Sarasota
Cleveland Clinic Florida
NOT_YET_RECRUITING
Stuart
Baycare Health Systems Clearwater
RECRUITING
Winter Haven
Georgia
Emory University
RECRUITING
Atlanta
Georgia Arrhythmia Consultants and Research Institute
RECRUITING
Warner Robins
Iowa
University of Iowa Hospitals and Clinics
RECRUITING
Iowa City
Illinois
Loyola University Chicago
RECRUITING
Chicago
Northwestern University
RECRUITING
Chicago
Rush University Medical Center
RECRUITING
Chicago
University of Chicago
RECRUITING
Chicago
University of Illinois Chicago
RECRUITING
Chicago
Alexian Brothers Health System
RECRUITING
Elk Grove Village
NorthShore University HealthSystem
RECRUITING
Evanston
Midwest Cardiovascular Institute
RECRUITING
Naperville
Indiana
Ascension St. Vincent
RECRUITING
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Boston Medical Center
RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Lahey Hospital & Medical Center
RECRUITING
Burlington
UMass Chan Medical School
RECRUITING
Worcester
Maryland
Johns Hopkins Univeristy
RECRUITING
Baltimore
Maine
Maine Medical Partners MaineHealth Cardiology
RECRUITING
Scarborough
Michigan
Henry Ford Health
RECRUITING
Detroit
Corewell Health (Former Spectrum Health)
RECRUITING
Grand Rapids
Trinity Health Grand Rapids/Mercy Health
RECRUITING
Grand Rapids
William Beaumont Hospital
RECRUITING
Royal Oak
Trinity Health Michigan Heart - Ann Arbor
RECRUITING
Ypsilanti
Minnesota
Essentia Health The Duluth Clinic
RECRUITING
Duluth
Hennepin Healthcare Research Institute
RECRUITING
Minneapolis
University of Minnesota
RECRUITING
Minneapolis
Missouri
University Health Truman Medical Center
TERMINATED
Kansas City
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Wake Forest Baptist Health
RECRUITING
Winston-salem
New Jersey
Hackensack Meridian Health
RECRUITING
Hackensack
Rutgers, the State University of New Jersey
RECRUITING
Piscataway
The Valley Hospital, Inc.
RECRUITING
Ridgewood
New Mexico
Presbyterian Healthcare Services
RECRUITING
Albuquerque
University of New Mexico Health Sciences Center
RECRUITING
Albuquerque
New York
University at Buffalo
RECRUITING
Buffalo
Columbia University Medical Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Weill Medical College of Cornell University
RECRUITING
New York
NewYork Presbyterian - Queens
RECRUITING
Queens
Staten Island University Hospital-Northwell Health
RECRUITING
Staten Island
Stony Brook University
RECRUITING
Stony Brook
Westchester Medical Center
RECRUITING
Valhalla
White Plains Hospital
RECRUITING
White Plains
Ohio
The Lindner Center for Research and Education at The Christ Hospital
RECRUITING
Cincinnati
University of Cincinnati College of Medicine
RECRUITING
Cincinnati
Ohio State University Medical Center
RECRUITING
Columbus
Wooster Community Hospital
RECRUITING
Wooster
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Allegheny Singer Research Institute
RECRUITING
Pittsburgh
Penn State Health Medical Group Berks Cardiology
RECRUITING
Wyomissing
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
MUSC Health Heart and Vascular
RECRUITING
Columbia
Texas
Texas Cardiac Arrhythmia Research Foundation
RECRUITING
Austin
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Baylor College of Medicine
RECRUITING
Houston
Houston Methodist Hospital
RECRUITING
Houston
University of Texas Health Science Center at Houston
RECRUITING
Houston
Virginia
University of Virginia
RECRUITING
Charlottesville
Virginia Commonwealth University
RECRUITING
Richmond
Washington
St. Joseph Medical Center Tacoma
RECRUITING
Tacoma
Wisconsin
University of Wisconsin
RECRUITING
Madison
Medical College of Wisconsin Froedtert Hospital
RECRUITING
Milwaukee
Contact Information
Primary
Shea Smith
reactaf_stanfordcc@stanford.edu
650-725-3187
Time Frame
Start Date: 2023-07-13
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 5350
Treatments
Experimental: AFSW Guided DOAC
All participants randomized to the experimental arm will be provided with an AFSW that will be linked to the participants Apple watch and the secure REACT-AF app within the Eureka cloud. The AFSW will intermittently and passively assess for rhythm irregularities consistent with AF and notify the wearer and coordinating center if a threshold AF event has occurred.
Active_comparator: Continuous DOAC therapy
All participants randomized to the control arm will remain on previously prescribed FDA-approved DOAC regimen as indicated by current practice standards. These participants will continuously take DOAC through the course of the study as prescribed by the participants primary physician unless otherwise contraindicated. Participants in the control arm will also use the REACT-AF mobile app within the Eureka platform via Apple watch for study follow-up activities, but the participants will not receive an AFSW and any personally owned Apple Watch will not be loaded with the customized REACT-AF detection algorithm nor participant notification apps.
Related Therapeutic Areas
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov